Registration Dossier
Registration Dossier
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EC number: 946-764-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26, May 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directives 91/325
- Principles of method if other than guideline:
- Results were interpreted according to the Council Dir. 83/467/EEC adapting for the 50th time Council Dir. 67/548/EEC .
- GLP compliance:
- no
Test material
- Reference substance name:
- D-Glucopyranose, oligomeric, C10-14-alkyl glycosides tartaric esters, sodium salt
- EC Number:
- 946-764-7
- Molecular formula:
- -
- IUPAC Name:
- D-Glucopyranose, oligomeric, C10-14-alkyl glycosides tartaric esters, sodium salt
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Breeding "Conelli" - Arona, Italy
- Weight at study initiation: 2,5 - 3,5 kg
- Housing: stainless steel cages of mm 450 x 500 x 380 with automatic washing cycle
- Diet (e.g. ad libitum): pellet complete diet
- Water (e.g. ad libitum): filtered water from local network
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 °C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): at least 25 times per hour
- Photoperiod (hrs dark / hrs light): 12 h/day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 ml/animal
- Observation period (in vivo):
- 1-24-48 and 72 hours and 7 days from instillation
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- Each animal had an eye treated and the other eye which remained untreated, as a control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 60 minutes
- Score:
- > 0 - < 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- > 0 - < 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48, 72h and 7 days
- Score:
- > 0 - < 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 60 min, 24,48,72 h and 7 days
- Score:
- > 0 - < 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 60 min
- Score:
- > 0 - < 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 24,48 h
- Score:
- > 0 - < 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 72 h and 7 days
- Score:
- > 0 - < 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Chemosis
- Basis:
- mean
- Time point:
- other: 60 min, 24,48,72 h and 7 days
- Score:
- > 0 - < 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Irritant
- Conclusions:
- Not irritant for eyes
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